To participate in departmental and industry-sponsored research projects with primary functions devoted to study coordination. Working with study investigators, patients, and administrators in accordance with human subject's research and finance and Good Clinical Practice, and GWU contracts management guidelines.
Essential Duties and Responsibilities include the following. To perform this job successfully, this individual must show a wide degree of creativity and latitude, and perform each essential duty satisfactorily.
General Research responsibilities Provide daily research support and administrative support for all assigned research projects and related activities.
*Facilitate the preparation of research grant and contract proposals and related budgets and justification documents.
*Collects and provides as requested, all research grant and contract support materials including biographical sketches, CVs, non-disclosures, study surveys, 1572 forms, and other related technical documentation, necessary to conduct research.
*Collects and presents, as requested, study budget information on a regular basis for the purpose of forecasting research expenditures and balances.
*Conducts on-line research as needed to support ongoing and future research projects.
*Assist in education and training of surgeons, residents and medical students in the field of research; conducts study in-services.
*Attends Division of Surgical Research committee meetings. IRB Forum and other conferences as requested.
Sponsored Clinical Trials
*Prepare and participate in study approval visits, site initiation visits and sponsored travel to investigator meetings
*Knowledge of IRB, FDA and contract regulatory requirements
*Conduct clinic visits with research participants - data collection (questionnaires and interviews) per protocol.
*Recruit and consent participants for research studies
*Complete case report forms per study sponsor guidelines
*Experience with sponsored study data collections, reporting, auditing, etc.
*Track, and report all participant adverse reactions
*Create Study participant binders
*Prepare for and participate in study audits by IRB and sponsors
*Enter participant data into study database, when necessary
*Maintain study-specific records related to invoices, payments and related issues
*Perform all procedures as necessary per study protocol
*May require travel 2-3 times a year to investigator meetings or conferences
Requirements Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EducationBachelors of Science, Masters Degree preferred in clinical or public health area.
ExperienceMinimum five years of relevant clinical research administration experience highly desirable
Supervision Received Supervision is received daily from the Director of the Division of Surgical Research.
Supervision Exercised As personnel in the Division come on board, may be asked to supervise junior researchers, interns, or administrative help